Method and apparatus for a fluid sampling device

ABSTRACT

Methods and apparatus are provided for manufacturing an analyte detecting device. In one embodiment, the apparatus comprises a housing; a penetrating member driver; a cartridge containing a plurality of penetrating members; a display on the cartridge; a linear slider on the housing, the slider coupled to a rod; and the rod moving with the slider, the rod having at least one roller. The device uses the linear motion of the slider to rotate the cartridge, punch open a new cavity and load a new penetrating member.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a National Stage Entry of PCT/US05/19445, whichclaims benefit of priority from provisional applications 60/577,376,filed Jun. 3, 2004 and 60/577,412, filed Jun. 3, 2004.

BACKGROUND OF THE INVENTION

Technical Field

The technical field relates to analyte detecting devices, and morespecifically, device for obtaining a fluid sample.

Background Art

Lancing devices are known in the medical health-care products industryfor piercing the skin to produce blood for analysis. Typically, a dropof blood for this type of analysis is obtained by making a smallincision in the fingertip, creating a small wound, which generates asmall blood droplet on the surface of the skin.

Early methods of lancing included piercing or slicing the skin with aneedle or razor. Current methods utilize lancing devices that contain amultitude of spring, cam and mass actuators to drive the lancet. Theseinclude cantilever springs, diaphragms, coil springs, as well as gravityplumbs used to drive the lancet. The device may be held against the skinand mechanically triggered to ballistically launch the lancet.Unfortunately, the pain associated with each lancing event using knowntechnology discourages patients from testing. In addition to vibratorystimulation of the skin as the driver impacts the end of a launcherstop, known spring based devices have the possibility of firing lancetsthat harmonically oscillate against the patient tissue, causing multiplestrikes due to recoil. This recoil and multiple strikes of the lancet isone major impediment to patient compliance with a structured glucosemonitoring regime.

Success rate generally encompasses the probability of producing a bloodsample with one lancing action, which is sufficient in volume to performthe desired analytical test. The blood may appear spontaneously at thesurface of the skin, or may be “milked” from the wound. Milkinggenerally involves pressing the side of the digit, or in proximity ofthe wound to express the blood to the surface. In traditional methods,the blood droplet produced by the lancing action must reach the surfaceof the skin to be viable for testing.

When using existing methods, blood often flows from the cut bloodvessels but is then trapped below the surface of the skin, forming ahematoma. In other instances, a wound is created, but no blood flowsfrom the wound. In either case, the lancing process cannot be combinedwith the sample acquisition and testing step. Spontaneous blood dropletgeneration with current mechanical launching system varies betweenlauncher types but on average it is about 50% of lancet strikes, whichwould be spontaneous. Otherwise milking is required to yield blood.Mechanical launchers are unlikely to provide the means for integratedsample acquisition and testing if one out of every two strikes does notyield a spontaneous blood sample.

Many diabetic patients (insulin dependent) are required to self-test forblood glucose levels five to six times daily. The large number of stepsrequired in traditional methods of glucose testing ranging from lancing,to milking of blood, applying blood to the test strip, and getting themeasurements from the test strip discourages many diabetic patients fromtesting their blood glucose levels as often as recommended. Tightcontrol of plasma glucose through frequent testing is thereforemandatory for disease management. The pain associated with each lancingevent further discourages patients from testing. Additionally, the woundchannel left on the patient by known systems may also be of a size thatdiscourages those who are active with their hands or who are worriedabout healing of those wound channels from testing their glucose levels.

Another problem frequently encountered by patients who must use lancingequipment to obtain and analyze blood samples is the amount of manualdexterity and hand-eye coordination required to properly operate thelancing and sample testing equipment due to retinopathies andneuropathies particularly, severe in elderly diabetic patients. Forthose patients, operating existing lancet and sample testing equipmentcan be a challenge. Once a blood droplet is created, that droplet mustthen be guided into a receiving channel of a small test strip or thelike. If the sample placement on the strip is unsuccessful, repetitionof the entire procedure including re-lancing the skin to obtain a newblood droplet is necessary.

Early methods of using test strips required a relatively substantialvolume of blood to obtain an accurate glucose measurement. This largeblood requirement made the monitoring experience a painful one for theuser since the user may need to lance deeper than comfortable to obtainsufficient blood generation. Alternatively, if insufficient blood isspontaneously generated, the user may need to “milk” the wound tosqueeze enough blood to the skin surface. Neither method is desirable asthey take additional user effort and may be painful. The discomfort andinconvenience associated with such lancing events may deter a user fromtesting their blood glucose levels in a rigorous manner sufficient tocontrol their diabetes.

A further impediment to patient compliance is the amount of time that atlower volumes, it becomes even more important that blood or other fluidsample be directed to a measurement device without being wasted orspilled along the way. Known devices do not effectively handle the lowsample volumes in an efficient manner. Accordingly, improved sensingdevices are desired to increase user compliance and reduce the hurdlesassociated with analyte measurement.

A further concern is the use of blood glucose monitoring devices in aprofessional setting. For the professional health care market, singledevice multiple user is the norm. A sterility barrier between patientsis required or a single use professional lancing device is used and thendiscarded after use. To interface an integrated point of care lancing,sampling and analyte detection device with a multiple user paradigm,each lancet analyte detecting member pair may be isolated from theprevious and subsequent user.

SUMMARY OF THE INVENTION

The present invention provides solutions for at least some of thedrawbacks discussed above. Specifically, some embodiments of the presentinvention provide an improved apparatus for improving the release ofpenetrating members from their cartridges. The present invention alsoprovided improved techniques for indexing and rotating the cartridge. Atleast some of these and other objectives described herein will be met byembodiments of the present invention.

The present invention provides solutions for at least some of thedrawbacks discussed above. Specifically, some embodiments of the presentinvention provide an improved apparatus for maintain sterility of adevice being used on multiple users. The device described belowfunctions to open the analyte detecting member channel and guide thesample into the analyte detecting member. It is then removed anddiscarded. Subsequent patient are protected as a new device is insertedto open the sensor at the time of lancing. The present invention mayalso provide improved techniques for manufacturing such analytedetecting devices. At least some of these and other objectives describedherein will be met by embodiments of the present invention.

In one embodiment of the present invention, the method comprisesobtaining a fluid sample by: removing the protective covering from thepackaging exposing a single item of sterile barrier film by pulling onthe tab provided; pressing the sterile barrier film to the front andunderside of the case; preparing a penetrating member by operating theslider on the side of the device and depressing the fire button once;pressing the center circular cutout in the foam front of the barrierfilm against the patients skin in the area to be lanced; lancing thepatient; and checking that the outer case of device has not beencontaminated by blood and if necessary clean it with disinfectant.

Methods and apparatus are provided for manufacturing an analytedetecting device. In one embodiment, the method comprises obtaining afluid sample by: removing the protective covering from the packagingexposing a single item of sterile barrier film by pulling on the tabprovided; pressing the sterile barrier film to the front and undersideof the case; preparing a penetrating member by operating the slider onthe side of the device and depressing the fire button once; pressing thecenter circular cutout in the foam front of the barrier film against thepatients skin in the area to be lanced; lancing the patient; andchecking that the outer case of device has not been contaminated byblood and if necessary clean it with disinfectant.

In one embodiment of the present invention, a fluid sampling device isprovided comprising a housing; a slider located on a surface of thehousing, wherein the slider movable in a linear direction to rotate thecartridge to bring an unused penetrating member into position for use.

In one embodiment of the present invention, a fluid sampling devicecomprising a housing; a cartridge defining a plurality of cavities, thecartridge sized to fit within the housing; and a plurality ofpenetrating members at least partially contained in the cavities of thecartridge wherein the penetrating members are slidably movable to extendoutward from the cartridge to penetrate tissue, the cavities each havinga longitudinal opening providing access to an elongate portion of thepenetrating member. The device may include a sterility barrier coupledto the cartridge, the sterility barrier covering a plurality of thelongitudinal openings, wherein the sterility barrier covering thelateral openings is configured to be moved so that the elongate portionmay be accessed by the gripper without touching the barrier; and aslider located on a surface of the housing, the slider movable in alinear direction to rotate the cartridge to bring an unused penetratingmember into position for use. A tooth gear may be coupled to the sliderto control a distance the slider can travel. A follower may be coupledto the slider. A cam surface may be engaged by the follower to lift thecartridge a desired distance above a first position to allow forrotation of the cartridge without engaging a gripper used to advance thepenetrating member.

The cam surface may be aligned parallel to the slider. The linear motionof the cam rotates the cartridge and moves a plunger to break thesterility barrier on the cartridge. The cam surface comprise a linearstrip of material with at least two raised portions and two depressedportions. The

In one embodiment of the present invention, a device is provided for usein penetrating tissue to obtain a body fluid sample. The devicecomprises a cartridge; and a plurality of penetrating members slidablycoupled to the cartridge, each of the penetrating members having adistal end sufficiently sharp to pierce tissue and each of thepenetrating members being moveable relative to the other ones of thepenetrating members, so that the distal end of the respectivepenetrating member is movable to penetrate tissue. Each of thepenetrating members may be a bare lancet does not penetrate an outersterility barrier during actuation.

In one embodiment of the present invention, a device may be providedcomprising a cartridge having a plurality of cavities; and a pluralityof penetrating members at least partially contained in the cavities ofthe single cartridge wherein the penetrating members are slidablymovable to extend outward from lateral openings on the cartridge topenetrate tissue. A sterility barrier may be coupled to the cartridge,the sterility barrier covering a plurality of the lateral openings,wherein the sterility barrier covering the lateral openings isconfigured to be moved so that a penetrating member exits the lateralopening without contacting the barrier. The sterility barrier may coverthe lateral openings and may be configured to be moved substantiallyvertically so that a penetrating member exits the lateral openingwithout contacting the barrier.

In one embodiment of the present invention, a device may be providedcomprising a housing; a penetrating member driver; a cartridgecontaining a plurality of penetrating members; a display on thecartridge; and a linear slider on the housing, the slider coupled to arod, wherein the rod moves with the slider, the rod having at least oneroller. The device may use the linear motion of the slider to rotate thecartridge, punch open a new cavity and load a new penetrating member.

In one embodiment of the present invention, a method is provided forindexing. The method comprises moving a linear slider; the linear slidercoupled to a rod; the rod moving with the slider, the rod having atleast one roller; using the linear motion of the slider and linearmotion of the rod to push at least one linear slider and to roll aroller along a linear cam surfaces to lift clear a drive assembly,rotate the cartridge, punch open a new cavity and load a new penetratingmember.

In one embodiment of the present invention, a fluid sampling device isprovided comprising a housing; a cartridge defining a plurality ofcavities, the cartridge sized to fit within the housing; and a pluralityof penetrating members at least partially contained in the cavities ofthe cartridge wherein the penetrating members are slidably movable toextend outward from the cartridge to penetrate tissue, the cavities eachhaving a longitudinal opening providing access to an elongate portion ofthe penetrating member. A sterility barrier may be coupled to thecartridge, the sterility barrier covering a plurality of thelongitudinal openings, wherein the sterility barrier covering thelateral openings is configured to be moved so that the elongate portionmay be accessed by the gripper without touching the barrier; and areplaceable tissue interface barrier located on the housing, wherein theinterface is replaced after each lancing event to prevent fluidcontamination between different users.

Replaceable tissue interface may be positioned about an opening on thehousing where the penetrating members extend outward to engage tissue ona user to obtain a fluid sample. Each of the cavities further include alateral opening. Replaceable tissue interface may comprise a pluralityof individually removable sheets of material, wherein one sheet isremoved prior to each lancing event to uncover a sterile unused sheet toprovide an uncontaminated surface for the next user to use.

In one embodiment of the present invention, a device is provided for usein penetrating tissue to obtain a body fluid sample. The devicecomprises a cartridge; and a plurality of penetrating members slidablycoupled to the cartridge, each of the penetrating members having adistal end sufficiently sharp to pierce tissue and each of thepenetrating members being moveable relative to the other ones of thepenetrating members, so that the distal end of the respectivepenetrating member is movable to penetrate tissue; wherein each of thepenetrating member is a bare lancet does not penetrate an outer,removable sterility barrier during actuation.

In one embodiment of the present invention, a device comprises acartridge having a plurality of cavities; and a plurality of penetratingmembers at least partially contained in the cavities of the singlecartridge wherein the penetrating members are slidably movable to extendoutward from lateral openings on the cartridge to penetrate tissue; asterility barrier coupled to the cartridge, the sterility barriercovering a plurality of the lateral openings, wherein the sterilitybarrier covering the lateral openings is configured to be moved so thata penetrating member exits the lateral opening without contacting thebarrier. A fluid contamination barrier may be located on a housing thedevice, the barrier being removed and replaced by a clean barrier priorto each lancing event.

In one embodiment of the present invention, a method is provided forobtaining a fluid sample. The method comprises removing the protectivecovering from the packaging exposing a single item of sterile barrierfilm by pulling on the tab provided; pressing the sterile barrier filmto the front and underside of the case; preparing a penetrating memberby operating the slider on the side of the device and depressing thefire button once; pressing the center circular cutout in the foam frontof the barrier film against the patients skin in the area to be lanced;lancing the patient; removing the barrier film from the front of thedevice; and checking that outer case of device has not been contaminatedby blood and if necessary clean it with disinfectant.

In one embodiment of the present invention, a method is provided forobtaining a fluid sample. The method comprises preparing the skin of thepatient in the area to be lanced with a sterile wipe; removing theprotective covering from the packaging exposing a single item of sterilebarrier film by pulling on the tab provided; removing the sterilebarrier film from the carrier by pulling on the applicator tab provided;applying the adhesive side to the front area of the device ensuring thatboth the outer circular holes in the barrier film fit around thematching circular bosses on the front of the device; pressing thesterile barrier film to the front and underside of the case taking carenot to touch the firing area of the barrier film; preparing apenetrating member by operating the slider on the side of the device anddepressing the fire button once; pressing the center circular cutout inthe foam front of the barrier film against the patients skin in the areato be lanced; lancing the patient by depressing the fire button a secondtime; removing the device from the patients skin and take the bloodsample from their skin; removing the barrier film from the front of thedevice using the tab provided and dispose of it properly; and checkingthat outer case of device has not been contaminated by blood and ifnecessary clean it with disinfectant.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of a controllable force driver in theform of a cylindrical electric penetrating member driver using a coiledsolenoid-type configuration.

FIG. 2A illustrates a displacement over time profile of a penetratingmember driven by a harmonic spring/mass system.

FIG. 2B illustrates the velocity over time profile of a penetratingmember driver by a harmonic spring/mass system.

FIG. 2C illustrates a displacement over time profile of an embodiment ofa controllable force driver.

FIG. 2D illustrates a velocity over time profile of an embodiment of acontrollable force driver.

FIG. 3 is a diagrammatic view illustrating a controlled feed-back loop.

FIG. 4 is a perspective view of a tissue penetration device havingfeatures of the invention.

FIG. 5 is an elevation view in partial longitudinal section of thetissue penetration device of FIG. 4.

FIG. 6 shows an exploded perspective view of one embodiment of a deviceaccording to the present invention.

FIG. 7 shows a cross-sectional view of one embodiment of a punchaccording to the present invention.

FIG. 8 shows another embodiment of a punch according to the presentinvention.

FIG. 9 shows one embodiment of a gripper with a shield.

FIGS. 10-12 show other embodiments of a gripper.

FIGS. 13-14 show embodiments of a gripper and a drive assembly.

FIGS. 15-16 show a cross-section and side view of one embodiment of thegripper and the drive assembly.

FIG. 17 shows a schematic of one embodiment of a slider used to rotate adisc.

FIGS. 18 through 21 are cut-away views of various elements of a deviceaccording to the present invention.

FIGS. 22-23 show embodiments of an analyte testing device for use with atest strip.

FIGS. 24-28 show various embodiments of a tissue interface.

FIG. 29 shows one embodiment analyte testing strip dispenser.

FIG. 30 through 35 shows various views of embodiments of a barrieraccording to the present invention.

FIGS. 36 through 40 show various close-up views of areas of the barrier.

FIG. 41 shows one embodiment of packaging for use with a barrieraccording to the present invention.

FIG. 42 shows a view of one portion of a cartridge for use with thepresent invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention provides a solution for body fluid sampling.Specifically, some embodiments of the present invention provides amethod for improving release of penetrating members for a cartridge. Theinvention may use a high density penetrating member design. It may usepenetrating members of smaller size, such as but not limited to diameteror length, than those of conventional penetrating members known in theart. The device may be used for multiple lancing events without havingto remove a disposable from the device. The invention may provideimproved sensing capabilities. At least some of these and otherobjectives described herein will be met by embodiments of the presentinvention.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed. It may be notedthat, as used in the specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to “a material”may include mixtures of materials, reference to “a chamber” may includemultiple chambers, and the like. References cited herein are herebyincorporated by reference in their entirety, except to the extent thatthey conflict with teachings explicitly set forth in this specification.

In this specification and in the claims which follow, reference will bemade to a number of terms which shall be defined to have the followingmeanings:

“Optional” or “optionally” means that the subsequently describedcircumstance may or may not occur, so that the description includesinstances where the circumstance occurs and instances where it does not.For example, if a device optionally contains a feature for analyzing ablood sample, this means that the analysis feature may or may not bepresent, and, thus, the description includes structures wherein a devicepossesses the analysis feature and structures wherein the analysisfeature is not present.

The present invention may be used with a variety of differentpenetrating member drivers. It is contemplated that these penetratingmember drivers may be spring based, solenoid based, magnetic driverbased, nanomuscle based, or based on any other mechanism useful inmoving a penetrating member along a path into tissue. It should be notedthat the present invention is not limited by the type of driver usedwith the penetrating member feed mechanism. One suitable penetratingmember driver for use with the present invention is shown in FIG. 1.This is an embodiment of a solenoid type electromagnetic driver that iscapable of driving an iron core or slug mounted to the penetratingmember assembly using a direct current (DC) power supply. Theelectromagnetic driver includes a driver coil pack that is divided intothree separate coils along the path of the penetrating member, two endcoils and a middle coil. Direct current is alternated to the coils toadvance and retract the penetrating member. Although the driver coilpack is shown with three coils, any suitable number of coils may beused, for example, 4, 5, 6, 7 or more coils may be used.

Referring to the embodiment of FIG. 1, the stationary iron housing 10may contain the driver coil pack with a first coil 12 flanked by ironspacers 14 which concentrate the magnetic flux at the inner diametercreating magnetic poles. The inner insulating housing 16 isolates thepenetrating member 18 and iron core 20 from the coils and provides asmooth, low friction guide surface. The penetrating member guide 22further centers the penetrating member 18 and iron core 20. Thepenetrating member 18 is protracted and retracted by alternating thecurrent between the first coil 12, the middle coil, and the third coilto attract the iron core 20. Reversing the coil sequence and attractingthe core and penetrating member back into the housing retracts thepenetrating member. The penetrating member guide 22 also serves as astop for the iron core 20 mounted to the penetrating member 18.

As discussed above, tissue penetration devices which employ spring orcam driving methods have a symmetrical or nearly symmetrical actuationdisplacement and velocity profiles on the advancement and retraction ofthe penetrating member as shown in FIGS. 2 and 3. In most of theavailable lancet devices, once the launch is initiated, the storedenergy determines the velocity profile until the energy is dissipated.Controlling impact, retraction velocity, and dwell time of thepenetrating member within the tissue can be useful in order to achieve ahigh success rate while accommodating variations in skin properties andminimize pain. Advantages can be achieved by taking into account of thefact that tissue dwell time is related to the amount of skin deformationas the penetrating member tries to puncture the surface of the skin andvariance in skin deformation from patient to patient based on skinhydration.

In this embodiment, the ability to control velocity and depth ofpenetration may be achieved by use of a controllable force driver wherefeedback is an integral part of driver control. Such drivers can controleither metal or, polymeric penetrating members or any other type oftissue penetration element. The dynamic control of such a driver isillustrated in FIG. 2C which illustrates an embodiment of a controlleddisplacement profile and FIG. 2D which illustrates an embodiment of athe controlled velocity profile. These are compared to FIGS. 2A and 2B,which illustrate embodiments of displacement and velocity profiles,respectively, of a harmonic spring/mass powered driver. Reduced pain canbe achieved by using impact velocities of greater than about 2 m/s entryof a tissue penetrating element, such as a lancet, into tissue. Othersuitable embodiments of the penetrating member driver are described incommonly assigned, copending U.S. patent application Ser. No.10/127,395, filed Apr. 19, 2002 and previously incorporated herein.

FIG. 3 illustrates the operation of a feedback loop using a processor60. The processor 60 stores profiles 62 in non-volatile memory. A userinputs information 64 about the desired circumstances or parameters fora lancing event. The processor 60 selects a driver profile 62 from a setof alternative driver profiles that have been preprogrammed in theprocessor 60 based on typical or desired tissue penetration deviceperformance determined through testing at the factory or as programmedin by the operator. The processor 60 may customize by either scaling ormodifying the profile based on additional user input information 64.Once the processor has chosen and customized the profile, the processor60 is ready to modulate the power from the power supply 66 to thepenetrating member driver 68 through an amplifier 70. The processor 60may measure the location of the penetrating member 72 using a positionsensing mechanism 74 through an analog to digital converter 76 linearencoder or other such transducer. Examples of position sensingmechanisms have been described in the embodiments above and may be foundin the specification for commonly assigned, copending U.S. patentapplication Ser. No. 10/127,395, filed Apr. 19, 2002 and previouslyincorporated herein. The processor 60 calculates the movement of thepenetrating member by comparing the actual profile of the penetratingmember to the predetermined profile. The processor 60 modulates thepower to the penetrating member driver 68 through a signal generator 78,which may control the amplifier 70 so that the actual velocity profileof the penetrating member does not exceed the predetermined profile bymore than a preset error limit. The error limit is the accuracy in thecontrol of the penetrating member.

After the lancing event, the processor 60 can allow the user to rank theresults of the lancing event. The processor 60 stores these results andconstructs a database 80 for the individual user. Using the database 79,the processor 60 calculates the profile traits such as degree ofpainlessness, success rate, and blood volume for various profiles 62depending on user input information 64 to optimize the profile to theindividual user for subsequent lancing cycles. These profile traitsdepend on the characteristic phases of penetrating member advancementand retraction. The processor 60 uses these calculations to optimizeprofiles 62 for each user. In addition to user input information 64, aninternal clock allows storage in the database 79 of information such asthe time of day to generate a time stamp for the lancing event and thetime between lancing events to anticipate the user's diurnal needs. Thedatabase stores information and statistics for each user and eachprofile that particular user uses.

In addition to varying the profiles, the processor 60 can be used tocalculate the appropriate penetrating member diameter and geometrysuitable to realize the blood volume required by the user. For example,if the user requires about 1-5 microliter volume of blood, the processor60 may select a 200 micron diameter penetrating member to achieve theseresults. For each class of lancet, both diameter and lancet tipgeometry, is stored in the processor 60 to correspond with upper andlower limits of attainable blood volume based on the predetermineddisplacement and velocity profiles.

The lancing device is capable of prompting the user for information atthe beginning and the end of the lancing event to more adequately suitthe user. The goal is to either change to a different profile or modifyan existing profile. Once the profile is set, the force driving thepenetrating member is varied during advancement and retraction to followthe profile. The method of lancing using the lancing device comprisesselecting a profile, lancing according to the selected profile,determining lancing profile traits for each characteristic phase of thelancing cycle, and optimizing profile traits for subsequent lancingevents.

FIG. 4 illustrates an embodiment of a tissue penetration device, morespecifically, a lancing device 80 that includes a controllable driver179 coupled to a tissue penetration element. The lancing device 80 has aproximal end 81 and a distal end 82. At the distal end 82 is the tissuepenetration element in the form of a penetrating member 83, which iscoupled to an elongate coupler shaft 84 by a drive coupler 85. Theelongate coupler shaft 84 has a proximal end 86 and a distal end 87. Adriver coil pack 88 is disposed about the elongate coupler shaft 84proximal of the penetrating member 83. A position sensor 91 is disposedabout a proximal portion 92 of the elongate coupler shaft 84 and anelectrical conductor 94 electrically couples a processor 93 to theposition sensor 91. The elongate coupler shaft 84 driven by the drivercoil pack 88 controlled by the position sensor 91 and processor 93 formthe controllable driver, specifically, a controllable electromagneticdriver.

Referring to FIG. 5, the lancing device 80 can be seen in more detail,in partial longitudinal section. The penetrating member 83 has aproximal end 95 and a distal end 96 with a sharpened point at the distalend 96 of the penetrating member 83 and a drive head 98 disposed at theproximal end 95 of the penetrating member 83. A penetrating member shaft201 is disposed between the drive head 98 and the sharpened point 97.The penetrating member shaft 201 may be comprised of stainless steel, orany other suitable material or alloy and have a transverse dimension ofabout 0.1 to about 0.4 mm. The penetrating member shaft may have alength of about 3 mm to about 50 mm, specifically, about 15 mm to about20 mm. The drive head 98 of the penetrating member 83 is an enlargedportion having a transverse dimension greater than a transversedimension of the penetrating member shaft 201 distal of the drive head98. This configuration allows the drive head 98 to be mechanicallycaptured by the drive coupler 85. The drive head 98 may have atransverse dimension of about 0.5 to about 2 mm.

A magnetic member 102 is secured to the elongate coupler shaft 84proximal of the drive coupler 85 on a distal portion 203 of the elongatecoupler shaft 84. The magnetic member 102 is a substantially cylindricalpiece of magnetic material having an axial lumen 204 extending thelength of the magnetic member 102. The magnetic member 102 has an outertransverse dimension that allows the magnetic member 102 to slide easilywithin an axial lumen 105 of a low friction, possibly lubricious,polymer guide tube 105′ disposed within the driver coil pack 88. Themagnetic member 102 may have an outer transverse dimension of about 1.0to about 5.0 mm, specifically, about 2.3 to about 2.5 mm. The magneticmember 102 may have a length of about 3.0 to about 5.0 mm, specifically,about 4.7 to about 4.9 mm. The magnetic member 102 can be made from avariety of magnetic materials including ferrous metals such as ferroussteel, iron, ferrite, or the like. The magnetic member 102 may besecured to the distal portion 203 of the elongate coupler shaft 84 by avariety of methods including adhesive or epoxy bonding, welding,crimping or any other suitable method.

Proximal of the magnetic member 102, an optical encoder flag 206 issecured to the elongate coupler shaft 84. The optical encoder flag 206is configured to move within a slot 107 in the position sensor 91. Theslot 107 of the position sensor 91 is formed between a first bodyportion 108 and a second body portion 109 of the position sensor 91. Theslot 107 may have separation width of about 1.5 to about 2.0 mm. Theoptical encoder flag 206 can have a length of about 14 to about 18 mm, awidth of about 3 to about 5 mm and a thickness of about 0.04 to about0.06 mm.

The optical encoder flag 206 interacts with various optical beamsgenerated by LEDs disposed on or in the position sensor body portions108 and 109 in a predetermined manner. The interaction of the opticalbeams generated by the LEDs of the position sensor 91 generates a signalthat indicates the longitudinal position of the optical flag 206relative to the position sensor 91 with a substantially high degree ofresolution. The resolution of the position sensor 91 may be about 200 toabout 400 cycles per inch, specifically, about 350 to about 370 cyclesper inch. The position sensor 91 may have a speed response time(position/time resolution) of 0 to about 120,000 Hz, where one dark andlight stripe of the flag constitutes one Hertz, or cycle per second. Theposition of the optical encoder flag 206 relative to the magnetic member102, driver coil pack 88 and position sensor 91 is such that the opticalencoder 91 can provide precise positional information about thepenetrating member 83 over the entire length of the penetrating member'spower stroke.

An optical encoder that is suitable for the position sensor 91 is alinear optical incremental encoder, model HEDS 9200, manufactured byAgilent Technologies. The model HEDS 9200 may have a length of about 20to about 30 mm, a width of about 8 to about 12 mm, and a height of about9 to about 11 mm. Although the position sensor 91 illustrated is alinear optical incremental encoder, other suitable position sensorembodiments could be used, provided they posses the requisite positionalresolution and time response. The HEDS 9200 is a two channel devicewhere the channels are 90 degrees out of phase with each other. Thisresults in a resolution of four times the basic cycle of the flag. Thesequadrature outputs make it possible for the processor to determine thedirection of penetrating member travel. Other suitable position sensorsinclude capacitive encoders, analog reflective sensors, such as thereflective position sensor discussed above, and the like.

A coupler shaft guide 111 is disposed towards the proximal end 81 of thelancing device 80. The guide 111 has a guide lumen 112 disposed in theguide 111 to slidingly accept the proximal portion 92 of the elongatecoupler shaft 84. The guide 111 keeps the elongate coupler shaft 84centered horizontally and vertically in the slot 102 of the opticalencoder 91.

Referring now to FIG. 6, a still further embodiment of a cartridgeaccording to the present invention will be described. FIG. 6 shows oneembodiment of a cartridge 300 which may be removably inserted into anapparatus for driving penetrating members to pierce skin or tissue. Thecartridge 300 has a plurality of penetrating members 302 that may beindividually or otherwise selectively actuated so that the penetratingmembers 302 may extend outward from the cartridge, as indicated by arrow304, to penetrate tissue. In the present embodiment, the cartridge 300may be based on a flat disc with a number of penetrating members suchas, but in no way limited to, (25, 50, 75, 100, . . . ) arrangedradially on the disc or cartridge 800. It should be understood thatalthough the cartridge 300 is shown as a disc or a disc-shaped housing,other shapes or configurations of the cartridge may also work withoutdeparting from the spirit of the present invention of placing aplurality of penetrating members to be engaged, singly or in somecombination, by a penetrating member driver.

Each penetrating member 302 may be contained in a cavity 306 in thecartridge 300 with the penetrating member's sharpened end facingradially outward and may be in the same plane as that of the cartridge.The cavity 306 may be molded, pressed, forged, or otherwise formed inthe cartridge. Although not limited in this manner, the ends of thecavities 306 may be divided into individual fingers (such as one foreach cavity) on the outer periphery of the disc. The particular shape ofeach cavity 306 may be designed to suit the size or shape of thepenetrating member therein or the amount of space desired for placementof the analyte detecting members 808. For example and not limitation,the cavity 306 may have a V-shaped cross-section, a U-shapedcross-section, C-shaped cross-section, a multi-level cross section orthe other cross-sections. The opening 810 through which a penetratingmember 302 may exit to penetrate tissue may also have a variety ofshapes, such as but not limited to, a circular opening, a square orrectangular opening, a U-shaped opening, a narrow opening that onlyallows the penetrating member to pass, an opening with more clearance onthe sides, a slit, a configuration as shown in FIG. 75, or the othershapes.

In this embodiment, after actuation, the penetrating member 302 isreturned into the cartridge and may be held within the cartridge 300 ina manner so that it is not able to be used again. By way of example andnot limitation, a used penetrating member may be returned into thecartridge and held by the launcher in position until the next lancingevent. At the time of the next lancing, the launcher may disengage theused penetrating member with the cartridge 300 turned or indexed to thenext clean penetrating member such that the cavity holding the usedpenetrating member is position so that it is not accessible to the user(i.e. turn away from a penetrating member exit opening). In someembodiments, the tip of a used penetrating member may be driven into aprotective stop that hold the penetrating member in place after use. Thecartridge 300 is replaceable with a new cartridge 300 once all thepenetrating members have been used or at such other time or condition asdeemed desirable by the user.

Referring still to the embodiment in FIG. 6, the cartridge 300 mayprovide sterile environments for penetrating members via seals, foils,covers, polymeric, or similar materials used to seal the cavities andprovide enclosed areas for the penetrating members to rest in. In thepresent embodiment, a foil or seal layer 320 is applied to one surfaceof the cartridge 300. The seal layer 320 may be made of a variety ofmaterials such as a metallic foil or other seal materials and may be ofa tensile strength and other quality that may provide a sealed, sterileenvironment until the seal layer 320 is penetrate by a suitable orpenetrating device providing a preselected or selected amount of forceto open the sealed, sterile environment. Each cavity 306 may beindividually sealed with a layer 320 in a manner such that the openingof one cavity does not interfere with the sterility in an adjacent orother cavity in the cartridge 800. As seen in the embodiment of FIG. 6,the seal layer 320 may be a planar material that is adhered to a topsurface of the cartridge 800.

Depending on the orientation of the cartridge 300 in the penetratingmember driver apparatus, the seal layer 320 may be on the top surface,side surface, bottom surface, or other positioned surface. For ease ofillustration and discussion of the embodiment of FIG. 6, the layer 320is placed on a top surface of the cartridge 800. The cavities 306holding the penetrating members 302 are sealed on by the foil layer 320and thus create the sterile environments for the penetrating members.The foil layer 320 may seal a plurality of cavities 306 or only a selectnumber of cavities as desired.

In a still further feature of FIG. 6, the cartridge 300 may optionallyinclude a plurality of analyte detecting members 308 on a substrate 822which may be attached to a bottom surface of the cartridge 300. Thesubstrate may be made of a material such as, but not limited to, apolymer, a foil, or other material suitable for attaching to a cartridgeand holding the analyte detecting members 308. As seen in FIG. 6, thesubstrate 322 may hold a plurality of analyte detecting members, such asbut not limited to, about 10-50, 50-100, or other combinations ofanalyte detecting members. This facilitates the assembly and integrationof analyte detecting members 308 with cartridge 300. These analytedetecting members 308 may enable an integrated body fluid samplingsystem where the penetrating members 302 create a wound tract in atarget tissue, which expresses body fluid that flows into the cartridgefor analyte detection by at least one of the analyte detecting members308. The substrate 322 may contain any number of analyte detectingmembers 308 suitable for detecting analytes in cartridge having aplurality of cavities 306. In one embodiment, many analyte detectingmembers 308 may be printed onto a single substrate 322 which is thenadhered to the cartridge to facilitate manufacturing and simplifyassembly. The analyte detecting members 308 may be electrochemical innature. The analyte detecting members 308 may further contain enzymes,dyes, or other detectors which react when exposed to the desiredanalyte. Additionally, the analyte detecting members 308 may comprise ofclear optical windows that allow light to pass into the body fluid foranalyte analysis. The number, location, and type of analyte detectingmember 308 may be varied as desired, based in part on the design of thecartridge, number of analytes to be measured, the need for analytedetecting member calibration, and the sensitivity of the analytedetecting members. If the cartridge 300 uses an analyte detecting memberarrangement where the analyte detecting members are on a substrateattached to the bottom of the cartridge, there may be through holes (asshown in FIG. 76), wicking elements, capillary tube or other devices onthe cartridge 300 to allow body fluid to flow from the cartridge to theanalyte detecting members 308 for analysis. In other configurations, theanalyte detecting members 308 may be printed, formed, or otherwiselocated directly in the cavities housing the penetrating members 302 orareas on the cartridge surface that receive blood after lancing.

The use of the seal layer 320 and substrate or analyte detecting memberlayer 822 may facilitate the manufacture of these cartridges 10. Forexample, a single seal layer 320 may be adhered, attached, or otherwisecoupled to the cartridge 300 as indicated by arrows 324 to seal many ofthe cavities 306 at one time. A sheet 322 of analyte detecting membersmay also be adhered, attached, or otherwise coupled to the cartridge 300as indicated by arrows 325 to provide many analyte detecting members onthe cartridge at one time. During manufacturing of one embodiment of thepresent invention, the cartridge 300 may be loaded with penetratingmembers 302, sealed with layer 320 and a temporary layer (not shown) onthe bottom where substrate 322 would later go, to provide a sealedenvironment for the penetrating members. This assembly with thetemporary bottom layer is then taken to be sterilized. Aftersterilization, the assembly is taken to a clean room (or it may alreadybe in a clear room or equivalent environment) where the temporary bottomlayer is removed and the substrate 322 with analyte detecting members iscoupled to the cartridge as shown in FIG. 6. This process allows for thesterile assembly of the cartridge with the penetrating members 302 usingprocesses and/or temperatures that may degrade the accuracy orfunctionality of the analyte detecting members on substrate 322. As anonlimiting example, the entire cartridge 300 may then be placed in afurther sealed container such as a pouch, bag, plastic molded container,etc. . . . to facilitate contact, improve ruggedness, and/or allow foreasier handling.

In some embodiments, more than one seal layer 320 may be used to sealthe cavities 306. As examples of some embodiments, multiple layers maybe placed over each cavity 306, half or some selected portion of thecavities may be sealed with one layer with the other half or selectedportion of the cavities sealed with another sheet or layer, differentshaped cavities may use different seal layer, or the like. The seallayer 320 may have different physical properties, such as those coveringthe penetrating members 302 near the end of the cartridge may have adifferent color such as red to indicate to the user (if visuallyinspectable) that the user is down to say 10, 5, or other number ofpenetrating members before the cartridge should be changed out.

Referring now to FIGS. 7 and 8, various embodiments of the presentinvention will now be described in further detail. Improvements havebeen made to the punch device 400. The present invention addressesissues with the punch moving the cut foil to the sides of the chamber,so that the foil springs back and you get some end effects where thepunch angles the foil into the corner, resulting in tearing rather thana clean cut to open the sterility barrier. The gripper has to bend thefoil out of the way, as it runs along the channel and this results inthe half Newton range or force required.

FIG. 7 shows an embodiment of the punch 400 with a widened portion 402that tightly fits against the opening of the cavity. Some embodimentsmay also have a flash portion 406 that interferes with the punch 400during punching. The helps push the flaps of the foil to the side anddoes not interfere with the gripper during travel.

FIG. 8 shows yet another embodiment with a narrow punch 410 with wingedportions 412. The wings 412 are of sufficient size and stiffness to pushthe foil pieces against the side of the cavities.

Referring now to FIGS. 9 through 16, a still further embodiment of thepresent invention describes a shield or guide rail attached to thegripper and not the punch. Thus the shield is in placed while thegripper is coupled to the penetrating member. It does not need to befitted to be exactly the same size as the cavity width, such as may beneeded by a punch, thus allowing for easier manufacturability.

Referring now to FIGS. 9 and 10, in this embodiment the shield 430 ismounted above the gripper 432. This hollow open channel rides over thegripper and is fixed to the track. It also guards from accidentallytouching the gripper itself. The present invention uses the guard tobend the foil out of the way.

Referring now to FIG. 11, a view of the gripper 432 engaged to apenetrating member and a shield 430 pushing foil aside is shown. FIG. 12shows yet another cross-section of the gripper 432 and shield 430. FIGS.13 and 14 shows yet another depiction with the entire gripper and driveassembly positioned over a cartridge 440 containing a plurality ofpenetrating members.

FIG. 15 shows a cross-section view with the entire gripper and driveassembly positioned over a cartridge 440 containing a plurality ofpenetrating members 442. FIG. 16 shows a perspective view of just thegripper and drive assembly.

In yet another embodiment of the present invention, there is now a newtype of punch proposed which will result in less friction and may beable to avoid a razor sharp blade and use a blunt blade instead. Thispunch has an “H” blade leaving an “H” cut which the guard now can foldnicely out of the way. The blade may be angled like a guillotine withfeet at either end to reduce the force needed to cut open the foil andhence we could maybe increase the foil thickness (we are at 12 micronsand would like to be at 20 to avoid pinholes (and hence bacteria/spores)

In a still further embodiment, the present invention may include animproved armature design. In one embodiment, the armature is madestiffer, by increasing diameter of the rod or going to a rectangularcross section in the place that suffers the most deflection. Bearingscan also be modified (in the cartridge); currently it is a round lancetin a square bearing. The plan is to set the lancet in a “V” channel andthen to provide a light downward force pressing the lancet into the “V”.As the lancet wants to move due to the asymmetrical chamfer, that forcewill be overcome and then it can move in compliance with eh chamferforce. We apply this force to the top of the gripper using a “V” shapetop on the gripper, the gripper is now stabilized so that it cant rattlearound, while maintaining the compliance for the lancet to move becauseof the chamfer. The end result is dampening of the oscillations in thearmature, thus reducing the jitter.

Space: to reduce the length of the travel of the slider due to spaceconstraints. One solution would be to ramp quickly and ramp up only whenneeded, therefore it becomes a non-linear cam arrangement. This gets usreduced length. In addition, it allows us to shorten the stroke. To getheight for PCB we can go from a double-sided cam to a single sided camwith a spring to provide the force in two directions.

Referring now to FIG. 17, yet another aspect of the present inventionwill now be described. To bring a new, unused penetrating member to use,the cartridge 500 may be rotated as indicated by arrow 502. A linearslider 510 moves forward and backward as indicated by arrow 512. Theforward motion of the slider 510 rotates the cartridge, among otherthings. In some embodiments, backward motion may be used to rotate thecartridge (it all depends on where the slider starts). Rotation occurswhen a keyed gear (not shown) that the opening 514 fits over is rotatedby motion of the slider 510. Of course, the slider 510 in the presentembodiment also actuates a plurality of other motions such as clearingthe gripper, shield, and drive assembly, to lift them clear so that thecartridge 500 can rotate.

Referring now to FIG. 18 shows how movement of the slider 510 moves rod520 as indicate by arrows 522. For ease of illustration, certainportions of the device are removed to allow easier visualization of themoving parts. The motion of rod 522 causes a second slider 530 to moveas indicated by arrow 532 and engage a stub 534 on the rotating wheel540. This wheel 540 turns the gear the fits inside the opening 514,which rotates the cartridge. In the present embodiment, a roller 550also travels on a cam surface 552.

As seen in FIG. 19, the roller 550 also move a slider 560. The rod 520also includes yet another roller 562. This roller as seen in FIG. 20,follows another cam surface 570. The cam surfaces 552 (FIG. 18) and 570(FIG. 20) allow for raising and lowering of the punch, shield, gripper,drive assembly, etc. . . . to allow for the cartridge to rotate and anew penetrating member cavity to be opened and a member loaded forfiring.

In some embodiments, the various steps that need to happen are similarto those described in commonly assigned copending U.S. patentapplication. Ser. No. 10/323,623 (38187-2607) filed Dec. 18, 2002.

FIG. 21 shows still further embodiments of the present invention. Itmore clearly shows some of the elements such as roller 562. Embodimentsusing the linear motion of the slider 510 and linear motion of the rod520 pushing linear sliders and pushing rollers to follow linear camsurfaces are very robust and will not easily fail. It should beunderstood that in some embodiments, a motor may be coupled to theslider to advance it instead of relying on user force.

Referring now to still further embodiments of the present invention:

1. C Shaped slug 3.6 mm—increase force outer diameter bigger, flux linesshorter saturates later so more force.

2. Ratchet finger: forces the punch cycle, removes peg pivot and springmechanism for the one-way action before return cycle is initiated. For Dlayout flexible finger which is s shaped—the S shape give the springlike action without the need for and extra spring. 6 parts to 2. Deletea coil spring and pins to hold it. It is small but injection moldable,p-ins are molded in.

4. Hinge on the gripper track: Attach the solenoid to the gripper trackso that the whole lot moves when the pull the gripper off the lancet.This is pivoted by bending so that the coil moves (and flag) but on thesensor just the flag in the slot.

5. Warping of disc: if the disc is over indexed (error) and rotationalerror in the gripper track then the shields will not be perfectlyaligned. The main pockets are now tapered to take care of this. Thewalls are now parallel (they were tapered before). Tapering allows theshields to only to touch in the back corner. This is being tested thisweek and may reduce the forces to push in and pull out (the fact that itis tapered. If the disc isn't flat downswards, the gripper can move downto follow the tract of the resilient to cartridge. Staticallydeterminant eg three legged stool on uneven floor. Takes into accountpoor manufacture in all parts including the gripper arm as well as theconsumable. Consistent friction with any changes that might occur due tomanufacturing. This is another advantage f the bearing system.

6. Collapsing cam mechanisms: ADA model—rolling beam slider needsmechanism so that it rolls back it punches but does not already punchthe nxt cavity. Ts a ratchet ball point pen mechanism. Slot and wheel ofADA is too thick. New one has metal component which latches in place,pushing punch down, pushes component backwards, so that hump disappears.The is called the return plate. (sliding plate was Dons idea, they addedmetal)

7. Punch force detection is also in this model

8. Capcitative sensing: 2 embodiments, electrically connected toneedle—since we have metal gripper and have an electrical circuit (theyhave model for needle sensing touching finger. Embodiment 2 pouching isnow repeated deals with pouching only.

9. Leak testing: hermetic seal check on each pocket—desiccate, dye.Cavities fill with ink—end up with depression in the foil over thecavity—its this depression they have not observed in combination withthe dye test. Foil thickness has not bee determined, 11 or 20 micronsare the two candidates. 20 might be too high too punch, it's the samethough, pin holes were less. If punch force stays low they will probablygo for the twenty micron. Dyye incress can sense 10 um and cmbi test wasless that 5 um.

10. Gripper stripper II chunk of plastic runs on track and pulls thegripper off the lancet. Does the same as the old cam but it is in twoparts at it is a thinner embodiment.

11. Plastic punches—swallowtail punch shape. Front punch the cuttingedge I creating a T shape. Back punch is hourglass shaped. Doing everyother one and going around twice. Main punch is wider at front on theback because chambers are now tapered. The edges at the center are thecutting; gabled ends act as shearing guillotine. Saggy roof(swallowtail), minimized the peak force over all the displacement, saggyroof achieves this.

12. This is D layout, cartridge is Saturn 31 aka Rev 5 Disc 08000009-2.Design features added to solve jitter and friction. Jitter spec 50microns, friction in the armature (moving assembly). Predictablerepeatable is better tan none or high friction. Changed the bearingsystem (armature) slug has carbon rod and sits in tube. The end of therd has a molding and the gripper. Lancet sits in cartridge and has twobearings, stroke is between the two bearings. The bearings are now Vshaped light force makes lancet sits in v, when it hits skin it can rideup the sides of the v when the lancet hits the skin. It moves due to the3 facet tip. This also allows a wide clearance. Before the result wasjitter, the v groove defines the position and clearance in 98 microns.Free flight free flight is zero because it is getting pushed int the v.Can now move left, right or twist and follow the tip into the skin, Theclearance at the rear and from are calculated to account for theorientation of the lancet into the skin it is free to move. The gripperis now mounted on a hinge and can rotate with the lancet. Plastic haselastic properties (delryn acetyl) is used for all springy parts in themodel. The gripper head is what rotates, not the gripper, so molding iscompliant to attach the gripper to the shaft. Slug is now diamondshaped. The damper sits on the rod and pushes down and applies the downwards pressure and damps out oscillation n the rod This takes some juicefrom the coil. 15 mN frictional force. Jitter plotted against frictionforce. Its below the 15 micron spec at 15 mN force at which contactpoint can be measured. Jitter under control by using friction Acomponent sets the friction so that it is reproducible, so controlsystem can compensate. There is some penalty in battery life—this has tobe determined. This is the new Bearing system. Gripper then gets lockedand then damper doesn't function while in the parked position. Thegripper track—the shield are pushed out of the way. They fold the slitsout of the way. Shield can maybe be used to keep the foil out of theway.

Referring now to FIG. 22, another embodiment of the present inventionwill now be described in greater detail. The device 1400 includes acartridge similar to that of FIG. 6, except that it only has penetratingmembers, no analyte sensing. In this embodiment, the device 1400 includea glucose or other analyte meter. A test strip 1410 may be inserted intoa slot on the device 1400 to allow for the body fluid on the test stripto be analyzed. As seen in FIG. 22, in different embodiments, the slotfor the strip 1410 may be inserted in a variety of locations (asindicated in phantom). In some embodiments, the electronic lancingdevice 1400 may also dispense the test strips from a cartridge orcassette held within the housing of the device 1400.

The electronic lancing device may use a radial cartridge for housing thepenetrating member or a bandolier type design as set forth in commonlyassigned, copending U.S. patent application Ser. No. 10/127,395(38187-2551) or PCT application No. PCT/US03/40095 (38187-2721).

Referring now to FIG. 23, a still further embodiment is shown where anattachment 1420 may be added to an electronic lancing device. Thisattachment, in one embodiment, contains a plurality of test strips fordispensing. In another embodiment, it may provide the electronics usedfor functioning as glucose or other analyte meter.

Referring now to FIGS. 24 through 28, these embodiments of the presentinvention relate to Point of Care lancing, sampling, sensing, anddisposable. The present invention provides a single device, suitable foruse with multiple users in situations such as POC applications in adultsor neonates. In one embodiment, the present invention address the issueby having a removable front end that both functions as a sampleacquisition device and a sterility barrier between uses of a singledevice with multiple users in a professional care environment.

Referring now to FIGS. 24 and 25, sample capture from the surface of thefinger may be carried out after the lancing step. A shield or guard mayprotect the front end from contamination and transfer of biohazardbetween successive patients. FIG. 24 shows that a portion 1422 may behydrophobic. FIG. 25 shows that there may be hydrophobic plate 1412 anda hydrophilic mesh 1414.

Referring now to FIG. 26, the present invention is a device 1425 thathas a plastic molded part with “tentacles” 1430 designed to remove thefoil covering of the analyte detecting member at the time the test istaking place. FIG. 27 shows some sizing of opening on the housing. Theplug may snap into the aperture of the front end. It protects back plateand front end from blood. Clips also remove packaging. FIG. 28 shows aperspective view of a fluid sampling device having a plurality of frontends 1425 on the device that are ready for use. FIG. 28 shows that oldor used front ends 1427 and new front ends 1429 may be placed on thehousing. By way of example and not limitation, they may be mounted onband on a back portion of the housing.

Two embodiments of the sampling paradigm are possible.

(1) The lancing is carried out in a separate operation and the surfaceof the finger is touched to the wicking or sip-in treated front end ofthe disposable “limpet” 1425. Blood is guided into the analyte detectingmember channel and the test is carried out. Post testing the “limpet”front end 1425 is removed and the disk indexed before inserting the next“limpet” for the next diagnostic test. The sample acquisition channel ofthe limpet can be configured with mesh to guide the sample to theanalyte detecting member or hydrophillically treated to guide the bloodto the analyte detecting member. Since POC tests require higher amountsof blood volume the dead space for the priming of the channel leading tothe not considered limiting. Limpets can be stored on board in theinstrument and dispensed as a cassette. They can also be disposed of inthe same cassette as used and then the entire cassette thrown way at theend of 25 or 50 patients have been tested.

(2) Embodiment two would allow an fluid device combined with analytedetecting members on a disk. The punch mechanism of the lancing devicecan open the seal. The function of the limpet would them be to attachand for a sterility barrier on the front end, allow passage of thepenetrating member through the center and perhaps contain surfacetreatment or mesh to guide the sample into the analyte detecting memberchamber. The limpet can be configured to prevent contamination in aside-to-side aspect between analyte detecting members by forming aphysical barrier between adjacent analyte detecting members. It can beconfigured to prevent splatter of blood on the back plane (inside of thefront end) of the instrument. It may also function as a fingerpositioning device as it can be contoured and shaped without affectingthe front face of the instrument.

Referring now to FIG. 29, these embodiments of the present inventionrelate to lancing, sampling, sensing, disposable, and manufacture. Inone embodiment, It is an integrated sampling/glucose-sensing system. Thepresent invention may integrate multiple lancings with multipleelectrochemical glucose sensing events. It is solved here, in someembodiments, in a very simple way by integrating the functions withoutintegrating the two different activities (lancing and sensing) in thesame physical device.

Referring again to FIG. 29, one particular simple integration of thefunctions of blood sampling and glucose-sensing is shown. In thisembodiment, a small package of disposable glucose sensing strips 1500 ina dispenser 1508 is physically adjoined to the lancing device. In orderto perform a glucose analysis, a user tears off/peels off a strip fromthe dispenser, sticks it to the front end of the lancing device (usingsuitable registration features on both the strip and the front end), andthen uses the device to lance and obtain blood. The strip 1500 has manyof the blood collection features, notably a woven lollipop structure toguide blood over an electrochemical glucose analyte detecting memberwhich is an integral part of the strip (the strip is very similar infunction to any glucose test strip). The front end of the lancing devicemay have electrode contacts which can either actively or passively makecontact with the electrochemical “signal out” pads of the strip. In aparticular embodiment of this concept, a hinged door be deployed fromthe lancing device front end to aid in registering the glucose strip andto make contact with the “signal out” pads. Following use, thedisposable glucose strip is removed from the front end of the device anddisposed of in the normal way.

A somewhat similar, but more integrated, approach is discussed. Here theglucose-sensing strips are still kept physically separate from themulti-lancing elements, and are only functionally integrated, but inthis embodiment, the glucose-sensing strips are integrated into theirown multi-strip roll. Using this multi-strip roll (in a cartridge verysimilar to an old 110 film canister), the indexing of the penetratingmember launcher can be used to move forward new, glucose strips. Theglucose strips in their roll move across the front end of the fluidsampling device, and perform similarly to the strips in the conceptabove. The strips have registration features corresponding toregistration features on the front end, and they have blood acquisitionmeans, like a woven lollipop structure, to guide blood from thefinger-lancing site to the electrochemical analyte detecting members.Contact to the “signal out” pads of the glucose test strips areaccomplished by electrode contacts integral to the front end of thefluid sampling device. But in this case, there are no individual stripseither to put on the front end of the fluid sampling, or to remove fromthe front end after use. The strips are deployed from a filmcanister-type cartridge, and are rolled back up into a similar canisterfeature on the other side of the fluid sampling after use. It is clearthat a multi-strip canister of this sort could be functionallyintegrated with a multiple penetrating member system of various forms. Amultiple-strip canister may be functionally integrated with multiplepenetrating members in the form of a penetrating member magazine, or aradial penetrating member cartridge.

Referring now to FIG. 30, still further embodiments of the presentinvention will be discussed. The technical field of these inventionsrelate to lancing, blood acquisition, contamination avoidance, steriledisposable materials. Most systems for gaining access to blood aresingle-use devices. Systems that are used to gain access to the blood ofmultiple people have the burden of showing that blood cannot be carriedfrom one user to another. A means for avoiding that “blood carry-over”is the subject of this invention. That means is basically a specificmaterial and design of tape that is used, and then discarded after use,between each patient.

Referring now to FIG. 30, one embodiment of a sterile disposableadhesive blood barrier 1600 is to be placed between the device and thepatient. The barrier 1600 may be applied to the exterior surface of thedevice before use with each patient and disposed of immediately afteruse. In the present embodiment, the adhesive blood barrier 1600 preventscontamination of any part of the device that may act as a pathway fortransmission of pathogens between patients. Illustrations of the designare shown in FIG. 30 shows the barrier by itself. FIG. 31 shows thebarrier 1600 attached to a fluid sampling device 1400. The barrier 1600may have a bend relief 1610, foam offset 1612 and location features 1614to help position the barrier properly. The port 1616 is where apenetrating member exits to piece tissue.

1.1. Description of Operation

As seen in FIG. 31, the user will apply the sterile adhesive bloodbarrier 1600 with foam pad to the front of the device and then place thepatients' fingertip or other skin surface against the high-density foamoffset pad in the firing area. The foam offset pad 1612 serves tomaintain a small air gap between the patients' finger and the bloodbarrier film. The penetrating member then is fired through the sterileadhesive blood barrier 1600 and enters the patient before retractingback into the cartridge. Testing described below has shown that thesmall hole created by the penetrating member, in combination with theair gap created by the foam, is highly resistant to fluid flow. Theblood barrier 1600 acts effectively in preventing transfer of blood tothe device despite the presence of such a hole.

In one embodiment, the selected film for the barrier 1600 ismanufactured by 3M Medical Tapes and Adhesives under the catalog name“3M™ Tan 5 mil Polyethylene Medical Tape 1523, 63# Liner”.

The selected foam is sold by Scapa Medical UK under the catalog name“Medifix 4005/868 Single Coated Medical Pressure Sensitive PolyurethaneFoam”. The offset pad is made up to the required thickness as amulti-layer laminate.

FIG. 32 is a cross-sectional diagram shows the relative dimensions ofthe proposed system prior to firing.

FIGS. 33, 34, and 35 are three diagrams that illustrate each phase ofthe lancing operation.

1.2. Prevention of Blood Transfer

First and foremost the film and foam prevent blood being left on thecasework of the device by being a simple physical barrier. In oneembodiment, the blood barrier 1600 will cover nearly the entire front ofthe device and also wrap underneath the device. User instructionsrequire that the user clean any obvious blood contamination that isspread outside the area of the barrier with a suitable disinfectantmethod.

The chief risk is that the blood will be transmitted to the device viathe hole created in the barrier film by the lancing operation. Thesuccess of the design relies on the elasticity of the selected filmclosing the hole, the surface tension and viscosity of the blood makingpassage through the small hole difficult, and the air gap providing foran alternative route in which the blood pressure can be releasedavoiding a pressure difference across the film.

Several experiments were completed to select a film and confirm that itsatisfied the requirement of preventing contamination of the device.

1.2.1. Hydrostatic Pressure Test

Objective: To test whether a suitable film and air gap could withstand ablood pressure equal to that in the capillary blood vessels of thepatient after being pierced by a penetrating member.

Method: A length of tubing filled with water was capped at one end by apiece of film intended to simulate skin. Offset from this “skin” was asample of the film being tested. The height of the free surface of waterwas set to the maximum pressure likely to be transmitted to the film bythe capillary bed, approximately 45 cmH20 (see below). A penetratingmember was pushed through the test film and the “skin” and then slowlywithdrawn whilst backlit and being filmed by a high speed macro videocamera. This process was repeated for a variety of films of differingmaterial and thickness.

Results: In the video footage it is obvious which combinations of airgap and film prevent fluid transmission. Results are presented in Table1 and it is shown that the selected film will prevent fluid transmissionfor pressures of at least 45 cmH20 when offset from the skin by 0.6 mm.

Pressure Air Gap Penetration Test Film Description Nature of film(cmH20) (mm) (Yes/No) 1 6016/877  40 um PU Hydrophilic 9 0 N 2 andelastic 10 0 N 3 12.5 0 Y 4 16 0 Y 5 Bioflex 140  25 um PU Hydrophilic10 0 N 6 and elastic 10.5 0 Y 7 RX941PLT  40 um PET Hydrophobic 10 0.6 N8 and inelastic 16 0.6 Y 9 1523 130 um PE Hydrophobic 20 0 Y 10 andelastic 25 0.6 N 11 30 0.6 N 12 32 0.6 N 13 45 0.6 N 14 45 0.6 N

The video footage shows the elastic closure of the hole as thepenetrating member is retracted. This closure reduces the area of thehole to a fraction of the penetrating member diameter increasing theresistance to fluid flow tremendously.

The elastic closure also prevents the penetrating member carrying withit large drops of blood to the device side of the barrier which mightotherwise be dislodged before the penetrating member is parked safely inthe cartridge. As the penetrating member retracts, the film closesaround it, wiping off any blood. Very small amounts of blood that mayadhere to the surface of the penetrating member and be carried back tothe device side of the barrier will be contained within the penetratingmember cavity.

1.2.2. Theoretical calculation

Theory governing fluid passage through a small hole states that therequired driving pressure for liquid to move through a small hole isgiven by:

$\begin{matrix}{P = \frac{4a}{d}} & {{Equation}\mspace{14mu} 1}\end{matrix}$

where: P is the driving pressure in Pa

a is the surface tension of the fluid in N/m

and d is the diameter of the hole in meters

The surface tension of blood has been shown to be in the region of56×10⁻³ N/m. The crescent shaped hole left by the penetrating memberafter elastic closure is approximately 6×10⁻⁹ m² in area (see “FIG. 36.Puncture hole with 0.317 mm diameter penetrating member for scale”),which is equivalent to hole with a diameter of 4.4×10-5 m. Equation 1therefore gives a required driving pressure of 5.10 kPa. Adhesion of theblood to the sharp corners of the hole is likely to make the actualrequired driving pressure significantly higher than this

The blood pressure in the capillary bed drops from a maximum of 30-35mmHg at the arterial end to 12-15 mmHg at the venous end. A pressure of30-35 mmHg equates to approximately 4.65 kPa or 45 cm H₂0. The actualpressure witnessed by the barrier and hole is likely to be significantlylower than this due to the presence of the air gap and the resistance toflow through the outer epidermis.

Theory therefore predicts that because the actual driving pressure isless than that required, fluid flow will not occur.

1.2.3. In Vivo Test

Objective: To confirm the laboratory experimentation the film selectionby in vivo testing using a prototype device and live patient.

Method: The barrier film and foam offset pad were applied to theprototype device. The device was then placed against the finger of thepatient and fired. The barrier was inspected on the Mitutoyo after thelancing operation at 96× magnification.

Result: The barrier film showed no transmission of blood. During thistesting it was also shown that the blood is not smeared on the bloodbarrier and that a sufficient sample of blood is left on the patientskin for analytical testing.

FIG. 37 shows a fluid sampling device with finger; FIG. 38 shows a blooddrop on patient side of film (16×); FIG. 39 shows device side of filmafter firing into finger (96×).

The laboratory tests and theoretical equations support the hypothesisthat the design is effective in preventing contamination of the deviceby blood.

1.3. Foreign Body Implantation

It is desirable that the penetrating member does not carry material fromthe adhesive blood barrier with it and implant it into the patient. Thefilm is an elastic and ductile material being punctured by a sharpenedpoint and it is therefore highly unlikely that pieces will be separatedoff and carried with the lubricated penetrating member tip. Thefollowing inspections were carried out to confirm this.

Method: A digital photograph of the penetrating member was takenimmediately after firing through the adhesive film. This inspection wasmade along the length of 10 penetrating members after firing through theadhesive film.

-   -   The film was inspected after firing through it.

A high frame-rate (2000 frames/second) digital video was taken of thelancing operation from the patient side.

Results: No plastic material or adhesive was seen stuck to thepenetrating member.

Inspection of the film using the Mitutoyo after piercing did not suggestthat material had been removed (see “FIG. 25. Barrier film afterpuncture (96× magnification)”).

No material removal was seen in the video footage.

Conclusion: Inspection of the penetrating member, the film and theprocess suggest that material is not removed during the firing process.

1.4. Sterility of the Blood Barrier

In one embodiment, the adhesive blood barrier 1600 will be prepared andpackaged in a cleanroom environment and then gamma sterilized. Theirrespective manufacturers have declared the selected film and foamsuitable for gamma sterilization. All manufacturing will be completed byan EN 13485 certified manufacturer and in accordance with that standard.

The barrier film will be presented to the user on a sterilizedimpermeable carrier and covered by another impermeable protective. Theblood barrier film is then only exposed to possible contaminants once itis removed from its packaging in preparation for use. Applicator tabsand location details will be help to reduce handling of the lancing areaas much as possible.

1.5. Cross Contamination Between Penetrating Members

In the current solution very small amounts of blood may adhere to thepenetrating member and travel back into the cartridge. Each penetratingmember is contained within its own cavity that is separated fromadjacent cavities and the mechanism. This separation is sufficient insize and geometry to prevent pathogens spreading. The adjacent unusedsterile penetrating member is hermetically sealed up until the time offiring. FIG. 42 Plan view of part of the penetrating member cartridge(protective foil not shown)” below show the layout of the cartridge inwhich the penetrating members are contained. From these drawings it canbe seen that the distance between penetrating members is large enough toprevent pathogens traveling between penetrating members even were theynot sealed.

1.6. Penetrating Member Damage

Operation of the device may be impeded and pain levels increased if thepenetrating member were to be damaged by the film before it entered thepatient skin. To check damage did not occur 5 penetrating members wereinspected before and after a lancing operation using the deviceprototype. The penetrating members showed no visible damage to thesharpened tip during the firing process.

1.7. Application of Barrier

Incorrect application might place the high-density foam offset pad inthe trajectory of the penetrating member or reduce the effectiveness ofthe foam in creating the air gap described above. To prevent suchmisapplication features are provided on the outer case of the fluidsampling Pro to match the geometry of the barrier film. These featuresmake misapplication obvious and reinforce the user instructions. Thefeatures are shown in

2. Appendix I: Instructions for Application of Barrier

Referring to the information below, one embodiment of the instructionsfor users of the fluid sampling Pro Penetrating member Launcher SterileBlood Barrier will be shown.

This device is for use by healthcare professionals only. It isrecommended that the operator wear sterile gloves when using the device.

1. Prepare the skin of the patient in the area to be lanced with asterile wipe.

2. Remove the protective covering from the packaging exposing a singleitem of sterile barrier film by pulling on the tab provided. Remove thesterile barrier film from the carrier by pulling on the applicator tabprovided. (See illustrations below)

3. Apply the adhesive side to the front area of the device ensuring thatboth the outer circular holes in the barrier film fit around thematching circular bosses on the front of the device.

4. Press the sterile barrier film to the front and underside of the casetaking care not to touch the firing area of the barrier film.

5. Prepare a penetrating member by operating the slider on the side ofthe device and depressing the fire button once. (See Lancing Device UserInstructions)

6. Press the center circular cutout in the foam front of the barrierfilm against the patients skin in the area to be lanced.

7. Lance the patient by depressing the fire button a second time.

8. Remove the device from the patients skin and take the blood samplefrom their skin.

9. Carefully remove the barrier film from the front of the device usingthe tab provided and dispose of it properly.

10. Check that outer case of device has not been contaminated by bloodand if necessary clean it with disinfectant.

FIG. 41 shows one embodiment of packaging for holding sterile barriers1600. The packaging 1700 may include a sterile carrier 1702 and aprotective cover 1704. Tabs 1706 may be used to facilitate pealing ofthe protective covers 1704.

FIG. 42 shows the possible areas of contamination and the barrier 1600is designed to minimize the flow of blood to these areas or to preventusers from coming in to contact with any blood on these areas.

While the invention has been described and illustrated with reference tocertain particular embodiments thereof, those skilled in the art willappreciate that various adaptations, changes, modifications,substitutions, deletions, or additions of procedures and protocols maybe made without departing from the spirit and scope of the invention.For example, with any of the above embodiments, the shield or otherpunch may be adapted for use with other cartridges disclosed herein orin related applications. With any of the above embodiments, a motor maybe directly coupled to rotate the cartridge.

The publications discussed or cited herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such publication by virtue of prior invention.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.All publications mentioned herein are incorporated herein by referenceto disclose and describe the structures and/or methods in connectionwith which the publications are cited. U.S. Provisional Application No.60/577,412 and U.S. Provisional Application No. 60/577,376 are fullyincorporated herein by reference for all purposes.

Expected variations or differences in the results are contemplated inaccordance with the objects and practices of the present invention. Itis intended, therefore, that the invention be defined by the scope ofthe claims which follow and that such claims be interpreted as broadlyas is reasonable.

What is claimed is:
 1. A fluid sampling device comprising: a housing; acartridge positioned in the housing a plurality of body fluid sensingstrips integrated into a multi-strip roll; at least one penetratingmember positioned in the cartridge; a gripper engaged to a penetratingmember; a drive assembly coupled to the cartridge; a member for movingthe cartridge to bring an unused penetrating member into position forlaunch, the member clearing the gripper and drive assembly to lift thegripper and drive assembly clear so that the cartridge can rotate; and asterile blood barrier with an offset pad to maintain an air gap betweena patients' finger and the sterile blood barrier, wherein the offset padis a multi-layer laminate, the sterile blood barrier including a bendrelief and one or more location features to position the sterile bloodbarrier.
 2. The device of claim 1 wherein a cam surface is alignedparallel to a slider.
 3. The device of claim 1 wherein a linear motionof a cam rotates the cartridge and moves a plunger to break thesterility barrier on the cartridge.
 4. The device of claim 1 wherein acam surface comprises a linear strip of maternal with at least tworaised portions and two depressed portions.
 5. A fluid sampling devicecomprising; a housing; a cartridge defining a plurality of cavities,said cartridge sized to fit within said housing; a plurality of bodyfluid sensing strips integrated into a multi-strip roll; a plurality ofpenetrating members at least partially contained in said cavities of thecartridge wherein each of a penetrating member is slidably movable, toextend outward from said cartridge to penetrate tissue; said cavitieseach having a lateral opening providing access to an elongate portion ofthe penetrating member; a gripper configured to be engaged with each ofa penetrating member; a drive assembly coupled to the cartridge; asterile blood barrier with an offset pad to maintain an air gap betweena patients' finger and the sterile blood barrier, wherein the offset padis a multi-layer laminate, the sterile blood barrier including a bendrelief and one or more location features to position the sterile bloodbarrier; and a member for moving the cartridge to bring an unusedpenetrating member into position for launch, the member clearing thegripper and drive assembly to lift the gripper and drive assembly clearso that the cartridge can rotate.
 6. A device comprising: a housing; apenetrating member driver; a cartridge containing a plurality ofpenetrating members; a plurality of body fluid sensing strips integratedinto a multi-strip roll; a display on said cartridge; a linear slider onthe housing, said slider coupled to a rod; said rod moving with saidslider, said rod having at least one roller using a linear motion of theslider to rotate the cartridge, punch open a new cavity and load anunused penetrating member; a gripper configured to be engaged with eachof a penetrating member; a driver coupled to the cartridge; a member formoving the cartridge to bring an unused penetrating member into positionfor launch, the member clearing the gripper and drive assembly to liftthe gripper and drive assembly clear so that the cartridge can rotate; asterile blood barrier with an offset pad to maintain an air gap betweena patients' finger and the sterile blood barrier wherein the offset padis a multi-layer laminate the sterile blood barrier including a bendrelief and one or more location features to position the sterile bloodbarrier.
 7. A device comprising: a cartridge having a plurality ofcavities; a plurality of body fluid sensing strips integrated into amulti-strip roll; a plurality of penetrating members at least partiallycontained in said cavities of the single cartridge wherein thepenetrating members are slidably movable to extend outward from lateralopenings on said cartridge to penetrate tissue; a sterile blood barrierwith an offset pad to maintain an air gap between a patients' finger andthe sterile blood barrier wherein the offset pad is a multi-layerlaminate, the sterile blood barrier including a bend relief and one ormore location features to position the sterile blood barrier; a gripperconfigured to be engaged with each of a penetrating member; a driveassembly coupled to the gripper; and a member for moving the cartridgeto bring an unused penetrating member into position for launch, themember clearing the gripper and drive assembly to lift the gripper anddrive assembly clear so that the cartridge can rotate.
 8. A method forobtaining a fluid sample comprising: removing a protective covering froma packaging exposing a single item of sterile blood barrier; positioningcartridge that contains a plurality of penetrating members in a positionto launch a penetrating member; using a plurality of body fluid sensingstrips in the form of an integrated multi-strip roll; engaging each of apenetrating member with a gripper; engaging the cartridge with a driveassembly; and moving the cartridge to bring an unused penetrating memberinto position for launch, the member clearing the gripper and driveassembly to lift the gripper and drive assembly clear so that thecartridge can rotate; providing a sterile blood barrier with an offsetpad to maintain an air gap between a patients' finger and the sterileblood barrier, wherein the offset pad is a multi-layer laminate, thesterile blood barrier including a bend relief and one or more locationfeatures to position the sterile blood barrier; and lancing the patient.9. The method of claim 8, wherein the sterile blood barrier is replacedfor each of a new patient.
 10. The method of claim 9, wherein thesterile blood barrier is placed between the device and the patient. 11.The method of claim 9, wherein the sterile blood barrier is used toprevent contamination of any part of the device that can be a pathwayfor transmission of pathogens between patients.
 12. The method of claim8, further comprising: a plurality of analyte sensing members, each ofan analyte sensing member associated with a penetrating member.
 13. Amethod of indexing comprising: providing a fluid sampling device thatincludes a housing, a plurality of penetrating members positioned in acartridge that is positioned in the housings and a plurality of analytesensing members; providing a plurality of body fluid sensing stripsintegrated into a multi-strip roll; using a gripper to engage with eachof a plurality of penetrating members; engaging the cartridge with adrive assembly; providing a sterile blood barrier with an offset pad tomaintain an air gap between a patients' finger and the sterile bloodbarrier, wherein the offset pad is a multi-layer laminate, the sterileblood barrier including a bend relief and one or more location featuresto position the sterile blood barrier; and using a member for moving thecartridge to bring an unused penetrating member into position forlaunch, the member clearing the gripper and drive assembly to lift thegripper and drive assembly clear so that the cartridge can rotate. 14.The method of claim 13, wherein a new disposable blood barrier is usedwhen a fluid sample is obtained for a different patient to preventcontamination from one patient to another patient.
 15. A fluid samplingdevice comprising: a housing; a cartridge positioned in the housing; aplurality of body fluid sensing strips integrated into a multi-striproll; at least one a penetrating member positioned in the cartridge; agripper engaged to a penetrating member; a drive assembly coupled to thegripper; a sterile blood barrier with an offset pad to maintain an airgap between a patients' finger and the sterile blood barrier, whereinthe offset pad is a multi-layer laminate, the sterile blood barrierincluding a bend relief and one or more location features to positionthe sterile blood barrier; and a member for moving the cartridge tobring an unused penetrating member into position for launch, the memberclearing the gripper and drive assembly to lift the gripper and driveassembly clear so that the cartridge can rotate.
 16. A fluid samplingdevice comprising: a housing; a cartridge defining a plurality ofcavities, said cartridge sized to fit within said housing; a pluralityof body fluid sensing strips integrated into a multi-strip roll; aplurality of penetrating members at least partially contained in saidcavities of the cartridge wherein each of a penetrating member isslidably movable to extend outward from said cartridge to penetratetissue, said cavities each having a lateral opening providing access toan elongate portion of the penetrating member; a gripper configured tobe engaged with each of a penetrating member; a drive assembly coupledto the cartridge; a sterile blood barrier with an offset pad to maintainan air gap between a patients' finger and the sterile blood barrier,wherein the offset pad is a multi-layer laminate, the sterile bloodbarrier including a bend relief and one or more location features toposition the sterile blood barrier; and a member for moving thecartridge to bring an unused penetrating member into position forlaunch, the member clearing the gripper and drive assembly to lift thegripper and drive assembly clear so that the cartridge can rotate.
 17. Adevice comprising: a cartridge having a plurality of cavities; aplurality of body fluid sensing strips integrated into a multi-striproll; a plurality of penetrating members at least partially contained insaid cavities of the single cartridge wherein each of the plurality ofpenetrating members is slidably movable to extend outward from lateralopenings on said cartridge to penetrate tissue, each of a lateralopening associated with a penetrating member; a sterile blood barrierwith an offset pad to maintain an air gap between a patients' finger andthe sterile blood barrier, wherein the offset pad is a multi-layerlaminate, the sterile blood barrier including a bend relief and one ormore location features to position the sterile blood barrier; a gripperconfigured to be engaged with each of a penetrating member; a driveassembly coupled to the cartridge; and a member for moving the cartridgeto bring an unused penetrating member into position for launch, themember clearing the gripper and drive assembly to lift the gripper anddrive assembly clear so that the cartridge can rotate.